Pharmaceutical compositions of polymeric micellar cinacalcet, and methods of preparation and use thereof
AssigneeHangzhou Shixi Pharmaceutical Technology Co., Ltd.
InventorsXiaoyan Sharon WANG, Xichen ZHANG
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Abstract
The present application provides pharmaceutical compositions of polymeric micellar cinacalcet suitable for intravenous or intraperitoneal administration, and methods of their preparation and use in treating various diseases and conditions (e.g., hyperparathyroidism and hypercalcemia).
Claims39
A pharmaceutical composition of cinacalcet, comprising micelles comprising cinacalcet, or a pharmaceutically acceptable salt thereof, and at least one amphiphilic block copolymer.
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A method for preparing a composition of polymeric micellar cinacalcet, comprising:
- dissolving at least one amphiphilic block copolymer and cinacalcet, or a pharmaceutically acceptable salt thereof, in an organic solvent, forming a first mixture;
- adding the first mixture to water or an aqueous solution with stirring;
- optionally removing the organic solvent, resulting in clear to translucent colloidal cinacalcet micelles;
- and optionally adding one or more pharmaceutically acceptable excipients, carriers or diluents;
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- dissolving at least one amphiphilic block copolymer and cinacalcet, or a pharmaceutically acceptable salt thereof, in an organic solvent, forming a first mixture;
- removing the organic solvent by evaporation, forming a matrix;
- adding water or an aqueous solution to the matrix, resulting in clear to translucent colloidal micelles;
- and optionally adding one or more pharmaceutically acceptable excipients, carriers or diluents.
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Dependencies are inferred from the claim text.